MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE SHIELDING HYPODERMIC NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305924
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple pma / 510(k)#s reported to be involved.The information for each 510(k) number is as follows: pma / 510(k)#: k980987 (syringe), pma / 510(k)#: k951254 (needle).Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 5 bd safetyglide¿ shielding hypodermic needles were missing their scale markings, and 1 syringe was found with the incorrect volume on it.All defects were found before use.The following information was provided by the initial reporter: "the syringe is missing the markings.One syringe had the incorrect volume on the syringe.".
Event or Problem Description
It was reported that 5 bd safetyglide¿ shielding hypodermic needles were missing their scale markings, and 1 syringe was found with the incorrect volume on it.All defects were found before use.The following information was provided by the initial reporter: "the syringe is missing the markings.One syringe had the incorrect volume on the syringe.".
Additional Manufacturer Narrative
H.6.Investigation summary: no samples displaying the condition reported are available for examination, so we were unable to fully investigate this incident.Corrective and preventative action (capa 753644) has already been initiated to determine the root cause of missing print and implement process improvements.No additional corrective actions are recommended for the complaints associated with this report.Corrective and preventative action was opened to investigate, will be applicable to the products made in the production line that manufactured batch 8289599.Device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see section h.10.
Additional Manufacturer Narrative
Bd is conducting a voluntary medical device recall (mds-20-3809) for a single lot of the bd safetyglide syringes.Printed scale markings on the lot of 3ml safetyglide syringes are printed incorrectly.The scale is skewed to different degrees, resulting in missing and/or partially printed scale numbers and scale lines.The use of a 3 ml syringe with incorrect scale marking could result in an inaccurate dose of medication being delivered to a patient.Although this issue would most likely be noticeable to the user, minimizing the impact to health, in a worst-case scenario, it could result in a potential inaccurate dose volume of up to 0.5ml.The root cause investigation is ongoing and will be documented in capa # 753644.
Event or Problem Description
It was reported that 5 bd safetyglide¿ shielding hypodermic needles were missing their scale markings, and 1 syringe was found with the incorrect volume on it.All defects were found before use.The following information was provided by the initial reporter: "the syringe is missing the markings.One syringe had the incorrect volume on the syringe.".

• Brand Name: BD SAFETYGLIDE SHIELDING HYPODERMIC NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8836414
• Report Number: 1213809-2019-00774
• Device Sequence Number: 1400805
• Product Code: FMI
• UDI-Device Identifier: 30382903059240
• UDI-Public: 30382903059240
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: SEE H.10.
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 09/30/2023
• Device Model Number: 305924
• Device Catalogue Number: 305924
• Device Lot Number: 8289599
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 07/12/2019; 07/12/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 09/19/2019; 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: MDS-20-3809
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other